Why the study?
There was concern that the nonthermal ablative mechanism of PFA might mask undiscovered compromises to clinical success.
Does PVI with a single-shot PFA catheter provide durable isolation and safety in patients with paroxysmal atrial fibrillation?
Does PVI with a single-shot PFA catheter provide durable isolation and safety in patients with paroxysmal atrial fibrillation?
PVI with a single-shot PFA catheter demonstrates excellent durability, acceptable safety, and low 1-year recurrence rates for paroxysmal atrial fibrillation.
May support single-shot PFA for paroxysmal AF; hypothesis-generating and requires randomized confirmation before practice change.
PVI with a "single-shot" PFA catheter results in excellent PVI durability and acceptable safety with a low 1-year rate of atrial arrhythmia recurrence. These data mitigate concern that the nonthermal ablative mechanism of PFA might mask undiscovered compromises to clinical success. (IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation, NCT03700385; A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation, NCT03714178; PEFCAT II Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation [PEFCAT II], NCT04170608).
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Reddy et al. (2021) studied this question.
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